Septo N'd Dimer Core Bu White 2x9g W/Tps

FDA UDI

Class II (US FDA UDI)

by Septodont

Identity

Trade Name: SEPTO N'D DIMER CORE BU WHITE 2X9G W/TPS FDA UDI
Generic Name: Dental composite resin FDA UDI
Model / Reference: 8581C FDA UDI

Identifiers

Primary DI / UDI-DI: 00303620001427 FDA UDI
FDA Product Code: EBF FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 9 Gram FDA UDI

Category: Dental composite resin

Septo N'd Dimer Core Bu White 2x9g W/Tps by Septodont — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
Forma S — ULTRADENT PRODUCTS, INC. · Class II
NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
SimpliShade — KERR CORPORATION · Class II
Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Septodont

Sources (1)

FDA UDI b2a7a9b6-767f-41c9-9bf4-e9880517c72e 35 fields · synced May 31, 2026